NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Optimized, Neuroplasticity-Enhanced-Depression (ONE-D) Transcranial Magnetic Stimulation (TMS) Treatment for Female Athletes With Co-morbid Depression and Concussion

NCT07507214

Not Yet RecruitingPhase 2, Phase 3

Sponsor: University of Florida

Conditions: Concussion, Depression

Interventions: ONE-D TMS protocol and d-cycloserine (125 mg)

Countries: United States

Concussion and depression have long been recognized to be intertwined pathologies.1-3 Although female athletes are more likely to suffer from mental health symptoms than males athletes following a concussion,2 research in this area has been largely biased toward males.4 Recently functional MRI (fMRI) studies5 in concussed athletes have established that there are patterns of local alterations in neural connectivity in the frontal cortex that demonstrate anatomic congruency with transcranial magnetic stimulation (TMS) studies that mapped alternations in neural connectivity to functional and somatic symptoms.6 Thus, there is potential that TMS treatment could decrease both symptom profiles, revolutionizing comorbid treatment options. Possible Benefits: Previous studies have showed a 70% remission rate for depression symptoms. It is possible that participants could have improvement in depressive or concussive symptoms after the ONE-D TMS treatment.

Eligibility overview

Sex: FEMALE

Age: 18 Years to 65 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Female athletes, both recreational and professional
* ages 18-65 years old
* Concussion as determined by clinical history (at least 72 hours post-diagnosis) and Post-Concussion Symptom Scale (PCSS) score above 7 OR more than 4 total symptoms present
* Depression as determined by Patient Health Questionnaire - (PHQ-9) score of 10 or greater indicating moderate depression or greater
* Treatment-resistant depression as determined by previously taken or currently taking an oral antidepressant for at least 6 weeks

Exclusion Criteria:

* Pregnant or breast-feeding individuals
* History of seizures or epilepsy
* Implanted devices (such as cochlear implants, brain stimulators, aneurysm clips or stents)
* Participants undergoing treatment with ototoxic medications (aminoglycosides, cisplatin)
* History of bipolar disorder
* Pacemakers or implanted defibrillators
* Allergy or other contraindications to d-cycloserine
* Other contraindications as determined by PI
* Unable to provide informed consent due to language or other barriers
* Incarceration
* Biological male gender

Locations (1)

Ocala, Florida, United States